Ex Parte Yamazaki et al

Patent Trials and Appeals Board

Feb 7, 2019

11968078 - (D) (P.T.A.B. Feb. 7, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/968,078 12/31/2007
108547 7590 02/11/2019
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
FIRST NAMED INVENTOR
Victoria Yamazaki
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
091628-0043/8002.US02 8181
EXAMINER
FOSTER, CHRISTINE E
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
02/11/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mweipdocket@mwe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VICTORIA YAMAZAKI, ROBERT J. SCHAFER,
MORRISON ULMAN, and JOHN T. GROVES
Appeal2018-002193
Application 11/968,078 1
Technology Center 1600
Before JEFFREY N. FREDMAN, ELIZABETH A. LA VIER, and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a screening method to identify candidate test agents that may bind to a
lipid bilayer-associated component. The Examiner rejected the claims on
appeal under 35 U.S.C. § 112 for failure to comply with the enablement
requirement, for failure to comply with the written description requirement,
and as directed to new matter. We have jurisdiction over the pending claims
under 35 U.S.C. § 6(b ).
1 According to Appellants, the real party in interest is Synamem Corp. App.
Br. 1.
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Application 11/968,078
We affirm.
STATEMENT OF THE CASE
The Specification discloses that "[ o ]ver the last several years, a
number of high-throughput screening methods have been developed to
facilitate the screening of thousands, if not millions, of compounds for a
desired activity or activities." Spec. 1. According to the Specification, these
methods are based on detecting binding, which is "effective at constraining
the universe of compounds which may have the desired activity," but which
is "not well-suited for evaluating this activity with any degree of detail." Id.
The Specification discloses that the biological activity of candidate
compounds is typically evaluated using "secondary screens," which require
"a substantial input of time by a trained technician or scientist." Id. Indeed,
"for candidate compounds affecting integral membrane proteins ... the
amount of time required per compound may be several hours or days." Id.
The Specification thus asserts that there "is a need for a more efficient
'secondary screen' of compounds affecting the activity of membrane
proteins, other lipid bilayer-associated and integral components, including
the lipids in the bilayer themselves to identify those few compounds that
justify further detailed analysis." Id.
The Specification asserts that the "present invention provides a
method for assaying an interaction between a test agent and a lipid-bilayer
and its associated and integral components." Id.
Claims 1, 3, 4, 9, 11, 13, 27-29, and 31 are on appeal. Claims 1 is
illustrative and reads as follows:
1. A screening method to identify candidate test agents that
may bind to a lipid bilayer-associated component, comprising:
providing a surface detector array device comprising
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(i) a substrate having a surface defining a plurality
of distinct bilayer compatible surface regions separated by
one or more bilayer barrier regions, said bilayer
compatible surface regions and said bilayer barrier regions
being formed of different materials, and
(ii) a plurality of lipid bilayer expanses comprising
lipids having acyl chains localized above said plurality of
distinct bilayer-compatible surface regions, wherein said
lipid bilayer expanses are localized above said surface
regions in the absence of covalent linkages between said
lipid bilayer expanses and said bilayer-compatible surface
regions, and are separated therefrom by an aqueous film
interposed between said bilayer-compatible surface
regions and said corresponding lipid bilayer expanses, at
least some of the lipids in the lipid bilayer expanses
comprising a component associated with the lipids to form
the lipid bilayer-associated component;
contacting said device with a bulk aqueous phase
comprising a known test agent at the gel-fluid transition
temperature of the lipids in the lipid bilayer expanses;
assaying for a change in the acyl chain mobility of
one or more of said lipid bilayer expanses to which the
known test agent has been added, as compared to the acyl
chain mobility of said one or more of said lipid bilayer
expanses to which the known test agent has not been
added, wherein assaying for a change in the acyl chain
mobility is performed by at least one of Fourier-
transformed infrared spectroscopy, sum frequency
generation spectroscopy, surface reflective spectroscopy,
surface plasmon spectroscopy, and imaging ellipsometry;
and
identifying the known test agent as a candidate test
agent that may bind to the lipid bilayer-associated
component when there is a change in acyl chain mobility
in the lipids comprising the lipid bilayer-associated
component as well as in lipids not associated with the
component.
Claim App 'x 3.
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The claims stand rejected as follows.
Claims 1, 3, 4, 9, 11, 13, 27-29, and 31 were rejected under 35 U.S.C.
§ 112 as failing to comply with the enablement requirement.
Claims 1, 3, 4, 9, 11, 13, 27-29, and 31 were rejected under 35 U.S.C.
§ 112 as failing to comply with the written description requirement.
Claims 1 and 27 were rejected under 35 U.S.C. § 112 as failing to
comply with the written description requirement for containing new matter.
FINDINGS OF FACT
1. The Specification discloses:
Acyl chain mobility may be evaluated using, e.g., electron-spin
labeled lipids as described in, e.g., Yin and Hyde, 1989,
incorporated herein by reference, or by FTIR, as described in,
e.g., Griffiths, et al., 1986, incorporated herein by reference,
sum frequency generation spectroscopy, or surface reflective
spectroscopy as described in, e.g., Kim, et al., 2002,
incorporated by reference.
Spec. 15.
2. The Specification discloses:
Of course, standard techniques such as fluorescence anisotropy
(see, e.g., Lackowicz, Principles of Fluorescence Spectroscopy.
Kluwer Academic/Plenum: New York (1999) (incorporated by
reference)), and fluorescence correlation spectroscopy (PCS)
(see, e.g., Hess, et al., 2002) also may be used to obtain
information about changes in membrane fluidity or acyl chain
mobility.
Spec. 26.
3. The Specification states: "The test agent may be any substance
whose interaction with a lipid bilayer or a component thereof is desired to be
tested. Exemplary test agents include small molecules, polypeptides,
antibodies, and biomolecules." Spec. 3.
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4. The Specification discloses:
The supported bilayer itself is a self-assembling, two-
dimensional fluid system, typically consisting of two opposed
leaflets of vesicle-forming lipid molecules. However, it can
be constructed as described below from any suitable
membrane-forming amphiphile, including proteins and
nonlipids.
Most vesicle-forming lipids are long-chain carboxylic acids,
such as glycerides, having the hydroxyl groups of the glycerol
esterified with (i) fatty acid chain(s), and (ii) a charged or
polar moiety, such as a phosphate-ester group. The vesicle-
forming lipids are preferably ones having two hydrocarbon
chains, typically acyl chains, and a polar head group. Long-
chain carboxylic acids with a phosphate group, or
phospholipids, are particularly well-suited for use with the
present invention. There are a variety of synthetic vesicle-
forming lipids and naturally occurring vesicle-forming lipids,
including the phospholipids, such as phosphatidylcholine
(PC), phosphatidylethanolamine (PE), phosphatidylserine
(PS), phosphatidic acid, phosphatidylinositol (Pl),
phosphatidylglycerol (PG), and sphingomyelin, where the
two hydrocarbon chains are typically between about 14-22
carbon atoms in length, and have varying degrees of
unsaturation. The above described lipids and phospholipids
whose acyl chains have varying degrees of saturation can be
obtained commercially or prepared according to published
methods. Other suitable lipids include glycolipids and sterols
such as cholesterol.
Preferred diacyl-chain lipids for use in the present invention
include diacyl glycerol, phosphatidyl ethanolamine (PE) and
phosphatidylglycerol (PG). These lipids are preferred for use
as the vesicle-forming lipid, the major liposome component,
and for use in the derivatized lipid described below. All of
these phospholipids and others are available from specialized
suppliers of phospholipids (e.g., Avanti Polar Lipids, Inc.,
Alabaster, Alabama) as well as from general chemical
suppliers, such as Sigma Chemical Co. (St. Louis, MO).
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Spec. 11.
5. Appellants and the Examiner agree that the Specification does
not include working examples of assaying for changes in acyl chain
mobility. Final Act. 4; App. Br. 6 ("The Examiner correctly notes there are
no working examples in the specification of methods of assaying for changes
in acyl chain mobility.").
6. The Specification states:
An important difference between egg - PC and DMPC
membranes is the gel- fluid transition temperature of DMPC
(23 °C), which is much higher than that of egg - PC.
Proximity to a gel - fluid transition may contribute to the
mobility effect observed in the DMPC system.
Spec. 35. The Specification does not make any other reference to the gel-
fluid transition temperature.
7. Example 2 of the Specification describes an experiment "to
illustrate the feasibility of utilizing the surface detector array device, or
'MembraneChipâ„¢,' for drug discovery." Id. at 21. In Example 2, "[t]he
MembraneChip™ was incubated with 1 ml of 2 µg/ml Texas Red-labeled
cholera toxin ... in phosphate buffered saline for 1 hour at room
temperature." Id. at 22.
8. Example 6 of the Specification describes an experiment to
examine "the mobility of a ligand ( cholera toxin), its membrane target
(ganglioside GMl ), and non-participating background lipid during
multivalent binding on fluid membrane surfaces." Id. at 33. It used DMPC
in the lipid bilayer of the surface detector array device. Id. at 34--35.
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ENABLEMENT
In finding that the claimed method was not enabled the Examiner
relies heavily on the fact that the Specification does not include any working
examples. Ans. 2-14; see also FF5. The Examiner notes that the claims
require identifying a test agent as a candidate test agent "when there is a
change in acyl chain mobility not only of the lipids comprising the lipid-
bilayer associated component (i.e., those lipids that are directly involved in
specific binding to the test agent) but also in lipids not associated with the
component (i.e., 'background' lipids that do not actually participate in
binding to the test agent)." Ans. 3. The Examiner also notes that "Appellant
has argued that a change in acyl chain mobility ... ' [ u ]nexpectedly' occurs
in the lipid bilayer-associated component as well as in lipids not associated
with the component." Id. 4. The Examiner concludes that "[n]o evidence
has been presented to show that any small molecule would be amenable to
screening by the claimed methods" and thus "one skilled in the art cannot
determine what test agents would be inoperative or operative." Id. at 12.
We are not persuaded.
"[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without 'undue experimentation."' In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993).
The enablement requirement ensures that the public knowledge
is enriched by the patent specification to a degree at least
commensurate with the scope of the claims. The scope of the
claims must be less than or equal to the scope of the
enablement. The scope of enablement, in tum, is that which is
disclosed in the specification plus the scope of what would be
known to one of ordinary skill in the art without undue
experimentation.
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Nat'! Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190,
1195-96 (Fed Cir. 1999).
The Examiner bears the burden of explaining why the scope of
protection claimed is not adequately enabled by the description of the
invention provided in the specification including, "providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement." In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993).
Appellants have persuaded us that the Examiner has not carried this burden.
In order to use the claimed method to identify a candidate test agent,
one must contact a "surface detector array device" with a "known test agent
at the gel-fluid transition temperature of the lipids in [a region of the detector
array device]" and assay for "a change in the acyl chain mobility" of lipids
in that region of the device as compared to lipids in a different region. With
respect to the "surface detector array device," the Specification provides
detailed guidance about its makeup. Spec. 9-14. With respect to the step of
contacting the device with a "test agent at the gel-fluid transition
temperature," the Examiner does not identify, and we do not find in the
record, evidence to support that the ordinary artisan would have required
undue experimentation in order to contact the claimed device with a test
agent at the recited temperature. Finally, with respect to the step of assaying
for a change in acyl chain mobility, the Specification identifies - and
incorporates by reference - prior art describing techniques that can be used
for evaluating acyl chain mobility. FFl, FF2.
The Examiner contends that "the specification lacks guidance with
regard to what experimental conditions would produce changes in acyl
change mobility necessary for successful operation of the claimed methods."
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Ans. 9. But the Examiner concedes that the level of skill in the art is high
(id. at 22) and does not identify persuasive evidence in the record providing
sufficient reason to doubt that the ordinary artisan would have been able to
assay for a change in acyl chain mobility using the known methods
described in the Specification. See FFI, FF2.
The Examiner contends that the art is unpredictable as evidenced by
the fact that "the background lipid probe NBD-PG did not exhibit binding-
related changes under all conditions, but rather only when a saturated
DMPC system was used." Ans. 6 (discussing Example 6 of the
Specification). According to the Examiner, this shows that "not all surface
detector array devices would produce changes in background lipids" and
thus changes in acyl chain mobility are "highly dependent on the lipid
composition of the surface detector array device." Id. However, the
Specification provides significant guidance on lipids that can be used in the
detector array device. FF4. The Examiner has not identified persuasive
evidence in the record providing sufficient reason to doubt that the ordinary
artisan would have been able to perform the claimed method using the lipids
identified in the Specification. Nor has the Examiner explained why the
scope of the claimed genus of "lipids having acyl chains ... " is
insufficiently represented by the suitable lipids disclosed in the
Specification. Id. Moreover, the claimed method is intended to test the
interaction of a particular lipid with a particular test agent. See FF3.
Accordingly, the evidence that NBD-PG exhibited binding-related changes
only when DMPC was used suggests that NBD-PG may be a "candidate test
agent" for DMPC but not for other lipids.
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The Examiner notes that there are "no working examples of assaying
non-local changes in acyl chain mobility," and points to Swamy2 as an
example in which the mobility of lipids was unaffected by binding. Ans. 7-
8. However, enablement does not require working examples, and the
Examiner has not persuasively explained why Swamy's finding that the
mobility of bulk lipids was not affected by binding of avidin reflects an
inability to carry out the claimed method rather than a result indicating that
avidin is not a suitable candidate test agent with respect to Swamy's bulk
lipids. See claim 1 (" ... identifying the known test agent as a candidate test
agent that may bind to the lipid bilayer-associated component when there is
a change in acyl chain mobility in the lipids comprising the lipid bilayer-
associated component as well as in lipids not associated with the
component").
For the reasons discussed above, the Examiner has not carried the
burden of providing sufficient reason to doubt the assertions made in the
Specification providing guidance on carrying out the claimed method.
Accordingly, we reverse the Examiner's rejection of the pending claims for
failing to comply with the enablement requirement.
WRITTEN DESCRIPTION
In rejecting the claims for failure to comply with the written
description requirement, the Examiner finds that the Specification does not
provide any examples in which the acyl chain mobility was assessed. Ans.
2 Swamy et al, Spin-Label Studies on the Anchoring and Lipid-Protein
Interactions of Avidin with N-Biotinylphosphatidylethanolamines in Lipid
Bilayer Membranes, 36 Biochemistry 7403-7407 (1997) ("Swamy").
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15. The Examiner also finds that the claimed method is unpredictable and
that "Appellant has not adequately described what interactions would be
amenable to indirect detection by detecting changes in acyl chain mobility,
and in particular by detecting non-local changes in acyl chains that are not
directly involved in binding." Id. More particularly, the Examiner finds that
the Specification "fails to disclose relevant, identifying characteristics shared
by test/agents/lipid bilayer-associated components that have the capacity to
change acyl change mobility upon binding interaction" and notes that the
Specification reflects that "not all interactions would result in such non-local
changes in acyl chain mobility." Id. at 16. Accordingly, the Examiner
concludes that the Specification "fails to demonstrate evidence of possession
of the entire claimed invention." Id. at 1 7.
Appellants argue that it is "immaterial if some binding events are not
detected in the present screen" because "[i]n that event, the ... test agents
are not identified as a candidate test agent." App. Br. 10. Appellants
contend that the claims do not require that there be a change in the acyl
chain mobility of any of the lipids. Id. Rather, the claims are directed to
screening method that identifies candidate test agents. Id. Pursuant to the
claimed method, test agents that cause a change in acyl chain mobility are
designated candidates, while test agents that do not cause a change are not.
Id. We find that Appellants have the better position.
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must "clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed." Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane) (quotation omitted,
alteration in original). "[T]he test for sufficiency is whether the disclosure of
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the application relied upon reasonably conveys to those skilled in the art that
the inventor had possession of the claimed subject matter as of the filing
date." Id. "If ... the specification contains a description of the claimed
invention, albeit not in ipsis verb is (in the identical words), then the
examiner ... , in order to meet the burden of proof, must provide reasons
why one of ordinary skill in the art would not consider the description
sufficient." In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
Here, as Appellants explain, the claims are directed to a method of
identifying a candidate test agent. App. Br. 10. The Specification provides
detailed guidance on the makeup of the "surface detector array device" used
to carry out the claimed method. Spec. 9-14. The Specification also
describes the lipids that may be used in the device (FF4) and, by
incorporation of prior art disclosures by reference, techniques that can be
used for evaluating acyl chain mobility. FFl, FF2. In sum, the Specification
describes the claimed method.
We acknowledge that the Specification does not include any working
examples in which the claimed method was employed to positively identify
a "candidate test agent." See FF5. We further acknowledge the Examiner's
argument that the Specification does not describe the characteristics of test
agents that the claimed method would positively identify as "candidate test
agents." Ans. 16. However, Appellants have not claimed a genus of
candidate test agents; they have claimed the method used to identify
candidate test agents. Because Appellants do not need to describe any
candidate test agents in order to comply with the written description
requirement, we reverse the Examiner's rejection of the pending claims for
failure to comply with the written description requirement.
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WRITTEN DESCRIPTION (NEW MATTER)
Claim 1
Claim 1 was amended to recite that the contacting step is performed at
the gel-fluid transition temperature of the lipids in the lipid bilayer expanses.
The Examiner finds that this limitation is not supported in the Specification.
Appellants argue that "[t]he combined teaching in Examples 2 and 6 provide
inherent basis for the recitation that contacting step is carried out at the gel-
fluid transition temperature of the lipids in the lipid bilayer expanses." App.
Br. 11. Appellants point out that Example 2 was carried out at room
temperature (23 QC) and that Example 6 uses DMPC as the lipid in the lipid
bilayer expanse. Id. Because the gel-fluid transition temperature of DMPC
is 23 QC, Appellants argue that the "specification as filed inherently provides
basis for the contacting step being carried out at the gel-fluid transition
temperature of the lipids in the lipid bilayer expanses." Id. Appellants also
note that the Specification "specifically recognizes that 'Proximity to a gel-
transition may contribute to the mobility effect observed in the DMPC
system."' Id. We find that the Examiner has the better position.
As an initial matter, Examples 2 and 6 of the Specification describe
separate experiments. FF7, FF8. Appellant has not identified, and we do
not find, a basis for extending the conditions of the experiments conducted
in Example 2 to Example 6 (or vice versa). Moreover, even if Examples 2
and 6 were combined to teach using DMPC at room temperature, the (purely
hypothetical) existence of a single example in which an experiment was
conducted at a temperature that aligns with the gel-fluid transition
temperature for the lipids used in the experiment - without explanation for
why the temperature was selected - does not inherently support a
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requirement to apply the gel-fluid transition temperature for all of the lipids
encompassed by the claim. Accordingly, Examples 2 and 6 do not support
choosing the temperature at which the test agent contacts the lipid bilayer on
the basis of the gel fluid transition temperature of the particular lipid used.
FF7, FF8.
We acknowledge Appellants' argument that the Specification states
that "[p ]roximity to a gel - fluid transition may contribute to the mobility
effect observed in the DMPC system." FF6. However, this statement is, on
its face, specific to "the DMPC system." We agree with the Examiner that
"there is no indication that Appellants contemplated performing the claimed
assays at the gel-fluid transition temperature, i.e.[,] that Appellants
contemplated varying the temperature depending on the particular lipids
being used." Ans. 29. As the Examiner explains, if it were the case that
Appellants intended to conduct assays at the gel-fluid temperature of the
particular lipids being used "it would be expected for this to be remarked
upon or recommended; or that subsequent assays using lipids other than
DMPC would have been performed at different temperatures to match the
gel-fluid transition temperature for that other lipid." Id. This is not the case.
Indeed, as the Examiner points out, "Example 7 used egg PC but does not
report adjusting the temperature to match the gel-fluid transition temperature
for that lipid." Id. Accordingly, we agree with the Examiner that the
Specification "does not clearly suggest that for lipids other than DMPC, ...
one should vary the reaction temperature to match the gel-fluid transition
temperature of the other lipids." Id. Even if it would have been obvious to
do so based on the Specification, "a description that merely renders the
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invention obvious does not satisfy the [ written description] requirement."
Ariad, 598 F.3d at 1352.
Because Appellants have not identified, and we have not found,
support in the Specification for choosing the temperature at which the test
agent contacts the lipid bilayer on the basis of the gel fluid transition
temperature of the particular lipid used, we affirm the Examiner's new
matter rejection of claim 1.
Claim 27
Claim 2 7 was added by amendment. It depends from claim 1 and
further requires that "the known test agent is a multivalent agent." The
Examiner finds that this limitation is not supported by the Specification.
Appellants argue that the Specification supports this limitation because the
Specification describes the pentameric B subunit of Cholera toxin (CTB)
and "antibodies" as exemplary test agents. App. Br. 12. In addition,
Appellants argue that the Specification supports limiting the test agents to
multivalent agents because it states that CTB participates in multivalent
bonding. Id. We find that the Examiner has the better position.
Claim 27 recites a genus - multivalent test agents. "[T]o satisfy the
written description requirement for a claimed genus, a specification must
describe the claimed invention in such a way that a person of skill in the art
would understand that the genus that is being claimed has been invented, not
just a species of the genus." Carnegie Mellon Univ. v. Hoffmann-La Roche
Inc., 541 F.3d 1115, 1124 (Fed. Cir. 2008). We acknowledge that the
Specification describes using test agents that are multivalent. However, the
Specification does not suggest selecting test agents on the basis that they are
multivalent. Indeed, in defining the term "test agent," the Specification
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suggests that test agents include small molecules, which may not be
multivalent. FF3. We also acknowledge that the Specification uses the term
"multivalent binding." It states:
The mobility of a ligand ( cholera toxin), its membrane target
(ganglioside GM 1 ), and non-participating background lipid
during multivalent binding on fluid membrane surfaces was
examined.
Spec. 33 (emphasis added). However, this passage simply describes the
binding of CTB to its target. It does not suggest selecting test agents on the
basis of their ability to engage in multivalent binding. Accordingly, we
affirm the Examiner's rejection of claim 27 as directed to new matter.
SUMMARY
In summary, we reverse the Examiner's rejection of claims 1, 3, 4, 9,
11, 13, 27-29, and 31 under 35 U.S.C. § 112 as failing to comply with the
enablement requirement.
We reverse the Examiner's rejection of claims 1, 3, 4, 9, 11, 13, 27-
29, and 31 under 35 U.S.C. § 112 as failing to comply with the written
description requirement.
We affirm the Examiner's rejection of claims 1 and 27 under 35
U.S.C. § 112 as failing to comply with the written description requirement
for containing new matter. 3
3 We designate this opinion as an affirmance because all of the pending
claims depend from claim 1, which has been rejected as containing new
matter. We do not designate this as a new ground of rejection because the
Examiner's written description rejection included all pending claims (Final
Act. 15), and the Examiner's new matter rejections were encompassed
within the written description rejection. See Final Act. 15-21.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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